The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency — making important discoveries that improve health and save lives.
This grant program supports the validation of molecular, cellular, and imaging markers for various applications in cancer treatment, including detection, diagnosis, prognosis, prediction of response or resistance to treatments, and prevention. It emphasizes the importance of developing clinical assays based on these biomarkers, with a focus on those relevant to chemotherapy, radiation therapy, and immunotherapy combinations. The program consists of two phases: the UH2 phase for analytical validation of assays, which must be completed within two years, and the UH3 phase for clinical validation of these assays, which can last up to three years. Validation efforts can also aim at existing assays for enhanced application in clinical trials, observational studies, or population research. Harmonization of clinical lab tests and improving assays' performance across clinical settings are also part of this grant's goals. It calls for multidisciplinary collaboration among researchers, oncologists, statisticians, and clinical laboratory scientists.